In an era where patient safety and regulatory compliance are more critical than ever, staying informed about global pharmacovigilance trends is essential. The Egyptian Drug Authority (EDA) recently released its 2023 Pharmacovigilance Inspection Metrics Report, offering a detailed look at inspection outcomes, key findings and areas for improvement.
Our experts break down the highlights of the report to help Marketing Authorization Holders (MAHs) and PV professionals understand what’s working and what needs attention.
What time period does the EDA’s 2023 report cover?
The report spans the full calendar year—from January 1 to December 31, 2023.
How many inspections were conducted during this period?
The EDA conducted 18 pharmacovigilance inspections in 2023.
What types of findings were reported?
The inspections revealed:
- 4 critical findings
- 42 major findings
- 57 minor findings
Where were the critical findings concentrated?
Critical issues were identified in:
- Implementation of Good Pharmacovigilance Practices (GVP) specific to Egypt obligations
- Agreements/contracts and Safety Data Exchange Agreements (SDEAs)
- Safety data migration processes
What about the major findings—what stood out?
The number of major findings per inspection ranged from zero to four. The most frequent issues were found in:
- GVP – Egypt obligations
- Quality Management Systems (QMS)
Can you break down the major GVP-related findings?
- Inadequate reporting of emerging safety issues
- Signal management
- Periodic Benefit-risk Evaluation Report (PBRER) management
- Problems with local literature screening
- Gaps in Risk Management Plan (RMP) management
What were the major QMS-related findings?
- Inspection readiness
- Procedural documentation
- Incomplete or outdated PSSF/PSMF maintenance
- Weaknesses in training
- Agreements and contracts
What’s the key takeaway from this report?
The EDA’s inspections highlight the critical need for strong pharmacovigilance systems. EVERSANA empowers Marketing Authorization Holders (MAHs) to proactively address core system vulnerabilities and maintain continuous inspection readiness. Our GVP audit and inspection readiness program—led by seasoned GVP auditors—is purpose-built to ensure MAHs are always prepared for regulatory scrutiny.
Author
Nitin is an accomplished professional with over 20 years of experience spanning Good Vigilance Practice (GVP), Good Clinical Practice (GCP), bioanalytical science and software validation. He previously held the Senior Manager – GVP QA…